V0202 Project Services

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V0202 Project Services

  1. 1. project services Flexible. Practical. Technical.Project services Science. We leverage more than 44 years of scientific and clinical research workforce expertise to support critical-path studiesProject Services is a dynamic service from Kelly® that provides across a range of therapeutic areas within our pharmaceutical,clients across the globe with a practical, technically driven biotech, and medical device clients who are leading the efforts toapproach to project-based endeavors. improve the quality of life across the globe.Rely on a partner you can to trust for project services including: Information technology. Our longstanding experience in • Scalable project development and deployment delivering technology workforce solutions helps clients drive• Customized PMO integration solutions innovation and cost reduction across IT disciplines including• Global talent delivery Applications Development & Integration, Software QA & Testing,• Targeted industry-specific expertise Data Warehousing & Business Intelligence, Data Storage,• Commercially viable project innovation Infrastructure Support and Network Engineering.As a leading workforce solutions provider, Kelly has industry-specific project expertise across complementary verticals:Engineering. Serving the engineering sector since 1965, we PMO integrationengage best-in-class project management methodologies, Are you lacking best-in-class projectsupport systems, and subject matter experts to provide our clients management methodologies, processes,with a high-quality, focused approach to project initiatives within and supporting tools? We’ll assess yourcommissioning, FDA validation and compliance, oil and energy,mining and minerals, and environmental management. gaps, develop a customized PMO platform for your organization, and manage the entire program until maturity.kellyservices.com
  2. 2. Continuum of service Project services life cycleKelly project managers utilize best-in-class methodology to provide a complete continuum of service for our clients, Pro jecwhile keepingt a constant eye on quality of service, the triple Defining Planning Implementing Manage ment Methodologyconstraint, and overall business objectives. ces ses d Pro Business Plans an Closing Monitoring Qu ality of Service (QoS) Plans Take a look at what you get within your timeframe and budget with project services from Kelly: Pro • Project scoping Planning ject Defining Implementing M anagement Methodology • Feasibility studies • PMO integration sses • Needs assessments d Proce Business Plans an • Gap analysis • Project design Closing Monitoring Qu ality • Change control of Service (QoS) Plans • Talent delivery • Process improvement • Quality reviews • Knowledge transfer • Lessons learned • Training updates • Close-out reports The Kelly Advantage
  3. 3. FDA liaison activitiesNeed assistance in interfacing with theFDA? Our regulatory experts can assist in developing your firm’s response to 483s and Warning Letters, as well as creating comprehensive corrective action programsto mitigate material deficiencies. FDA validation and compliance Clinical research and development To promote business continuity and compliance with regulatory We provide full service capabilities in biometrics, data guidelines, we offer a comprehensive line of validation, management, and clinical operations. Our team of technical and compliance, and quality services to our life sciences clients. scientific experts brings the knowledge and experience necessary Our team of subject matter experts is well versed on the most to assist research and development efforts within all phases: up-to-date guidance from the FDA and can bring a practical • Pre-clinical and animal understanding of interpretations required to mitigate risk • Phases I, II, III enterprise-wide. • Phase IV and post-marketing • PK/PD Capabilities cover the full range: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, Part 58 Biometrics We have experienced biostatisticians and statistical programmers Across the entire spectrum: CSV, GMP, GLP, GCP, GDP, GxP, ICH, supporting studies targeted toward NDA, BLA/ PLA, and MPA. CQV, equipment/utilities/facilities, process/cleaning/packaging We provide: • Statistical design and protocol development Engineering design qualification services: • Statistical analysis plans (SAPs) • Design qualification • Statistical reports and publication design/support • onducting vendor audits, FAT (factory acceptance testing), C • Statistical programming (SAS®) and analysis and SAT (site acceptance testing) • Summary tables, patient listings, and graphs • Software developer assessment • Integrated summaries of safety and efficacy (ISS/ISE) • pecifications – user requirements, functional requirements, S • Sample size and randomization and detailed design • Commissioning Clinical data management Our experts have significant experience in the following areas: • CRF design and printing • Database installs/upgrades • Medical coding • Data entry and validation • Data coordination and integrity • QC and edit checks • Electronic data capture (EDC) • Electronic submissions • Oracle® Clinical and ClintrialTM
  4. 4. IT solutions Need a partner who understands your business environment? Kelly supports more than 80 percent of the Information Week 500 companies. around the globe. Our IT talent pool is highly educated, mobile, and well versed in the latest systems, software, and hardware.Oil and natural gas Information technologyExploration and production Kelly has been on the leading edge of our client’s technologyOur highly skilled exploration and production teams focus on innovation and talent management for more than 45 years.delivering upstream production support—onshore and offshore, Combining world-class project methodology with our wide pool domestically and internationally—to the world’s largest energy of technical subject matter experts, we’re able to deliver practicalfirms. Our capabilities cover the wide spectrum. solutions to some of the industry’s most complex IT challenges.Field service and operations We employ a collaborative approach with our clients by engaging• DSMs/Superintendents for active rigs worldwide in a three-step process to ensure expectations are always set and• Degreed geologists deliverables are consistently met:• Health, safety, environmental (HSE) • Identifying and understanding your business drivers and impacts• Well planners (directional and straight-hole) • Developing and selecting the most cost-effective delivery models• Degreed MWD and LWD engineers • stablishing and monitoring project quality standards and E• Reservoir engineers oversight perimetersIndustrial mining Throughout the decades, we’ve accumulated the functionalClients turn to Kelly for industry-defined solutions to help drive and technical knowledge required to drive developmentproductivity and profitability. Our consultants have accumulated life cycles, improve quality and reliability, accelerate projectbest-in-class expertise across the globe supporting large capital schedules, and enhance our customer’s overall ability to stayprojects from exploration to mine performance management. competitive and innovative.Deploying a diverse and experienced team of personnel, we’re Selected areas of expertise include:able to address workforce shortages, productivity issues, and • loud Computing Ctechnology challenges to assist our clients in producing optimum • irtual Networks Voperational performance. • ata Warehouse & Business Intelligence D • nterprise Systems Integration and Customization EWorldwide capabilities within: • eb-based Technologies W• Pre-feasibility, feasibility, conceptual, and scoping studies • ealth Informatics H• Mining engineering services• HAZOP assessments and studies Environmental management• Mining information management systems Kelly understands the importance of conserving and restoring our natural resources, instituting sustainable communities, and decreasing our carbon footprints. Our engineers and scientists support leading efforts within the environmental industry to assess the impact of human activity and drive innovative, cost-effective, and practical solutions to improve our daily lives. Specific areas of project focus include: • Environmental assessments (EAs) • Environmental impact assessments (EIAs) • Natural Environmental Policy Act (NEPA) compliance • Air quality compliance • Geotechnical engineering • Water/Waste water management • Geographic information systems (GIS) specialists
  5. 5. Kelly Services globalinfrastructure AmErICAS EmEA ApAC Europe, Middle East, Asia-Pacific Temporary and Africa Temporary to Hire Direct Hire On-site Management Payroll Services Areas of Expertise Automotive Contact Center Creative Services Education Electronic Assembly Engineering Finance and Accounting Government Healthcare Industrial Information Technology Law Marketing Office Science project Services Project Teams Project Management PMO Integration SOW-based Services Outsourcing & Consulting Solutions Recruitment Process Outsourcing Business Process Outsourcing Contingent WorkforceFor more information, contact Kelly Services today. OutsourcingDaniel rhodes Human Resourcesphone :: 760.458.4505 ConsultingE-mail :: daniel.rhodes@kellyservices.com Career Transition & Organizational Effectivenessmichael ruchman Executive Searchphone :: 858.232.7110E-mail :: michael.ruchman@kellyservices.comkellyservices.comAll trademarks are property of their respective owners.An Equal Opportunity Employer © 2010 Kelly Services, Inc. V0202 R5/10

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